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510(k) Data Aggregation

    K Number
    K131711
    Device Name
    YZ3 PORTABLE SLIT LAMP
    Manufacturer
    SUZHOU 66 VISION TECH CO., LTD.
    Date Cleared
    2014-05-09

    (332 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    YZ3 PORTABLE SLIT LAMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The YZ3 Portable Slit Lamp is intended for use in the examination of the anterior segment of the eye.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the YZ3 Portable Slit Lamp. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The 510(k) letter confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use (examination of the anterior segment of the eye). It outlines regulatory compliance requirements but does not detail performance studies or testing results specifically.

    Therefore, I cannot provide the requested information based on the input text.

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